Mid-Level EMC Engineer - EE testing, 60601-1-2, Wireless testing certification

Our client is one of the largest medical device companies within the US that focuses on building devices and applications for vision and eyes. They have locations around the world and are looking for a Mid-level EMC Engineer - Product certification and wireless Electrical Engineer - to help test medical standards IEC60601-1 / -2 in the labs. this position will be within the R&D group and working the latest and greatest advanced devices used for surgery

This is a 1year+ contract to hire position that requires the right candidates to be on-site hybrid 4 days a week in their south orange county office.

Role Requirements :

Minimum Education and Experience :

BS + 2 years in medical device products safety compliance, or successfully working as medical device product safety officer in either / both medical device manufacturer and / or fully accredited test labs such as Element, UL, CSA and Intertek, etc.

Proven experience in successfully being able to work cross functional teams

Core responsibilities :

• Perform EMC and Wireless test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
• Research and develop product EMC & Wireless requirements including selection of applicable standards & tests, with analyses to support Alcon’s global market access strategies for all electromechanical surgical instruments.
• Support product development utilizing specialized EMI / EMC hardware and software within all stages of product development at the circuitry level (PCB level) as well as at the system level
• Support development including planning, communicating periodic status and known risks (with proposed solutions) on the projects to R&D core teams
• Capable of performing EMI / EMC testing and troubleshooting of Alcon products in the Alcon EMC Lab and external labs.
• Communicate with internal / external labs, technicians, and design engineers to accomplish timely / valuable results at optimal cost.
• Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals.
• Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed EMC and Wireless verification test plans and test reports.
• Effectively communicate complex concepts in formal / informal presentations and in technical reports; proven technical writing skills is required (assessed during interview).
• Experience with EMC testing of electrical equipment and certification of wireless devices for global market access.
• Experience with Product Safety testing requirements and procedures.
• Experience with use and maintenance of commonly used EMC and wireless test equipment.
• Working knowledge of IEC 60601-1-2, IEC 60601-4-2 medical standards. Proven experience in applying state-of-the-art EMC and RF design principles. Knowledge of IEC 60601 series of standard would be a plus.

Influence effectively in a cross-functional environment (e.g. multi-site, technical development, other functions).

The Offer :